Rules for Success

Over the past 40 years, the role of regulatory professionals has changed immensely. Factors such as the rapid pace of technological innovation, heightened global safety issues, and different and changing regulatory environments are just a few of the challenges that influence the regulatory landscape and, in turn, shape the profession.

In those years, some regulatory societies have seen their membership evolve as the dynamics of the profession have pivoted to meet regulatory and strategic demands. Membership has transformed from a collection of individuals from varied fields, tasked with the administrative aspects of a growing body of requirements, to a group of professionals who engage with the entire product lifecycles of their respective organisations. Regulatory teams link science, technology, and innovation with clinical needs and maintain a watchful eye on compliance and developments, policy, and good business practice.

This article discusses the evolving role of regulatory within the pharmaceutical industry, the importance of having a competent workforce, and how this profession can be a strategic driver of organisational success.

Dr William Bridges joined the Regulatory Affairs Professionals Society as Vice President of Education and Professional Development in January 2017. In his 20 years of experience, he has designed instructional materials and curriculum, created a vision for education and training programmes, and developed competency-guided roadmaps for learners in the military, academia, government, and association spheres. He also holds a PhD in history from the University of Nebraska, US and has taught for the University of Nebraska, US, Towson University, US, and the American public university system.

Reading Scientific Services Ltd (RSSL), a leading provider of scientific
and technical solutions to the global biopharmaceutical,
pharmaceutical, and biopharmaceutical sectors, has introduced the United
Kingdomís first same-day mycoplasma testing service for manufacturers
of biologic medicines.
More info >>

Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developerís mind set and a regulatory background in validation.
As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP).
Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
More info >>

Celebrating its 10th successful year, SCOPE Summit 2019 takes place
February 18-21 in Orlando, FL. Over the course of four stimulating days of
in-depth discussions in 19 different conferences, 3 plenary keynote sessions,
and the ever-popular interactive breakout discussions, the programming focuses
on advances and innovative solutions in all aspects of clinical trial planning,
management and operations, including...More info >>